Seroquel Problems Mount for AstraZeneca as First Trial Approaches
Published: December 8th, 2008 • Comments: 5
The first of several thousand lawsuits filed by Seroquel users who claim that AstraZeneca failed to warn about serious side effects of Seroquel, is scheduled for trial to begin in February 2009, and the problems for the drug maker continue to increase.
On Thursday, the FDA posted a warning letter on their website, which accused AstraZeneca of marketing Seroquel for un-approved uses, which the company has not established are safe or effective.
Seroquel (quetiapine fumarate) is an atypical antipsychotic which has not been approved for treatment of major depressive orders, yet the letter indicates a sales representative pitched this “off-label” use to a doctor and even sent promotional materials and study results, which the FDA indicates suggested a new intended use for Seroquel.
Although doctors are free to prescribe approved medications for un-approved uses, drug companies are prohibited by federal law from promoting or encouraging such use. The FDA concluded the statements of the drug rep and written materials provided, constituted misbranding of Seroquel and Seroquel XR, and demanded that AstraZeneca stop distributing the promotional materials.
AstraZeneca has been previously accused of marketing Seroquel for “off-label” uses, and some experts have estimated that as much as 70% of all Seroquel prescriptions have been for unapproved uses since the drug was first introduced in 1997.
As of November 5, 2008, AstraZeneca indicates that they are aware of 9.060 Seroquel lawsuits that have been filed in state and federal court involving a total of 15,026 plaintiffs. This means that the over 1,500 people have filed lawsuits over the two month period since the last update, when AstraZeneca reported that as of August 27, 2008, over 13,300 plaintiffs were involved in the Seroquel litigation.
The cases involve allegations that AstraZeneca failed to adequately warn about the risk of severe weight gain, diabetes, pancreatitis and other serious medical conditions associated with the use of their drug.
Although AstraZeneca has indicated that they intend to defend the cases, in another damaging blow, an internal document was released last week which suggests that the company was aware of the Seroquel diabetes side effects as early as 2000, yet failed to warn users about the potential risk.
According to Bloomberg News, an internal document from the drug maker’s global safety officer, Wayne Geller, concluded that there was “reasonable evidence” that Seroquel side effects cause diabetes and related conditions. The conclusions were based on studies and data which were available to the drug maker very early on after the drug was introduced.
All federal lawsuits over Seroquel have been consolidated in an MDL, or Multidistrict Litigation, which has been centralized in the U.S. District Court for the Middle District of Florida.
The first trial is scheduled to begin in February 2009, and the internal documents were publicly disclosed during hearings on Thursday and Friday of last week on motions filed by AstraZeneca over the qualifications of expert witnesses the plaintiffs intend to call at trial.
Pingback by FDA Requests Additional Information about Expanded Seroquel Use : AboutLawsuits.com on 29 December 2008:
[...] first trial in the Seroquel litigation is scheduled to begin in February 2009, and during pretrial motions earlier this month, an internal [...]
Pingback by Seroquel Diabetes Side Effects Increase Risk 389 Percent : AboutLawsuits.com on 19 January 2009:
[...] month, as part of pre-trial motions filed with the Seroquel Court, internal documents from AstraZeneca were publicly disclosed which indicate that the drug [...]
Pingback by Seroquel Diabetes Problems Kept From Doctors According to Unsealed Documents : AboutLawsuits.com on 3 March 2009:
[...] Pharmaceutical sales representatives were told to provide this information to doctors despite the fact that AstraZeneca’s own expert wrote nearly five years earlier that there was evidence of a relationship between Seroquel problems and diabetes. [...]
Comment by gary on 28 July 2009:
I was on seroqluel about three months and first the dosage was too much 300 mg /day It was almost the oleary days again then sure enough my pcp told me I had crossed th eline and have disabetie 11 and now some four lyears later I have been passing out at a rate of once every eight months and you don not know when this is going to hit as it just happens. I also have pancreatis and have had to ahve the gall bladder removed passed out and broke some disks in the lower back passe dout and cut my hear and got six stitches for it but thank the lord for seroqluel at 50 mg it seems alright
Comment by Pamela on 18 February 2010:
I have always had hypoglycemia, with a long fanily history of diabetes.
The seroquel I take is about 400 mg a day. I have started gaining weight and am always thirsty. My vision deterioates more and more. A new problem has been a burning and ache in one arm or leg at a time. I have to set down and can not walk. It is an intense pain and I try to rub my extremity but to no avail. I goes away after about 15 minutes but until the time passes I can not function.